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The FaSet Fixation System is intended to stabilize the spine as an aid to fusion through bilateral immobilization of facet joints. The Facet Screw System is indicated for posterior surgical treatment with or without bone graft at single or multiple levels from C2 to S1 (inclusive). For transfacet fixation, the screws are inserted posteriorly through the superior side of the facet, across the facet joint, and into the pedicle. For translaminar facet fixation, the screws are inserted posteriorly through the lateral aspect of the spinous process, through the lamina, through the superior side of the facet, across the facet joint, and into the pedicle. The FaSet Fixation System is indicated for treatment for any or all of the following:

• Spondylolisthesis
• Pseudoarthrosis or failed previous fusions which are symptomatic, or which may cause secondary instability or deformity
• Spondylolysis
• Degenerative Disk Disease (DDD) as defined by back pain of discogenic origin with degeneration of disk confirmed by history and radiographic studies and/or degenerative disease of the facets with instability
• Trauma including spinal fractures and/or dislocations.

The UNITY Sacroiliac Joint Fixation System is indicated for sacroiliac joint fusion for:

• Sacroiliac joint dysfunction including degenerative sacroiliitis and sacroiliac joint disruptions
• Augmenting immobilization and stabilization of the sacroiliac joint in skeletally mature patients undergoing sacropelvic fixation as part of a lumbar or thoracolumbar fusion

The UNITY Sacroiliac Joint Fixation System is also indicated for fracture fixation of acute, non-acute, and non-traumatic fractures involving the sacroiliac joint.

The Huvex Interspinous Fixation System is a posterior, non-pedicle supplemental fixation device intended for use in the lumbar spine (T1-S1) as an adjunct to fusion in skeletally mature patients. It is intended for plate fixation/attachment to the spinous processes for the purpose of achieving supplemental fusion in the following conditions: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fracture or dislocation), tumor, and/or lumbar spinal stenosis. The Huvex Interspinous Fixation System is intended for use, in conjunction with autogenous bone graft, and not intended for stand-alone use.

The AEON-C™ Stand Alone System is a stand-alone anterior cervical intervertebral fusion device indicated for use in skeletally mature patients with degenerative disc disease (DDD) with accompanying radicular symptoms at one or two contiguous levels from C2-T1. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. The AEON-C™ Stand Alone System should be packed with autograft and/or allograft comprised of cancellous, cortical and/or corticocancellous bone graft and implanted with an anterior approach. Patients should receive at least six (6) weeks of non-operative treatment prior to treatment with a cervical intervertebral fusion device. If the device is being used without the provided screws, supplemental fixation must be used.

The FaSet Fixation System consist of permanent implant devices manufactured from titanium or titanium alloy (Ti-6Al-4V ELI) as specified in ASTM F67, and F136. Various sizes and lengths of these implants are available to accommodate patient anatomy. The device is intended to provide mechanical support and stability to the implanted level until biologic fusion is achieved.

The UNITY Sacroiliac Joint Fixation System consists of screws designed to enhance sacroiliac joint fusion. The UNITY Sacroiliac Joint Fixation System is offered in various diameters, lengths, and three screw types in cannulated form to accommodate patient anatomy and is manufactured from titanium alloy (Ti-6Al-4V ELI) as specified in ASTM F136 and cobalt chrome alloy as specified in ASTM F1537. The three design types of the subject device are:

• 1. Standard Thread Screw (with and without slots)
• 2. Lag Screw (with and without slots) and
• 3. Washer Screw (with slots)

The Huvex Interspinous Fixation System consists of a left plate, a right plate, pin, bolt, inner cap, center bar, and set screw. Each of these components is provided in several sizes to allow for the construction of five different HUVEX Interspinous Fusion implant sizes. The left plate is provided assembled with the poly axial bar. The bar has a bone graft window to allow fusion between spinous process. Poly axial bar is also designed to fit the anatomical characteristics of the spinous process. The right plate is designed to be combined with left plate fixed to spinous process. Right plate contains a set screw to lock the right plate to the poly axial bar. The Huvex Interspinous Fixation System components are supplied non-sterile, are single use and are fabricated from titanium alloy (Ti-6AI-4V ELI) that conforms to ASTM F136.

In addition to the implants a set of reusable surgical instruments are provided. Both implant and instruments have trays that are used for handling and storage.

The AEON-C™ Stand Alone System includes PEEK interbodies and titanium interbodies, which utilize a titanium alloy locking mechanism that is either integrated in an anterior fixation plate or within the interbody. Both PEEK interbodies and titanium interbodies, with or without fixation plates, are to be anchored to patient anatomy via two (2) titanium alloy bone screws. The implant design includes multiple footprints, heights and lordosis options and the screw design includes multiple diameters and lengths, to fit a variety of patient anatomies. The interbodies can be used without the provided screws when supplemental fixation is used.

The provided document is a 510(k) summary for several medical devices: FaSet Fixation System, UNITY Sacroiliac Joint Fixation System, Huvex Interspinous Fixation System, and AEON-C™ Stand Alone System.

This document describes that the subject devices are substantially equivalent to their predicate devices, which means they are considered as safe and effective as a legally marketed device that does not require premarket approval.

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

This document does not contain specific quantitative acceptance criteria or reported device performance metrics in the way one would typically see for a novel diagnostic or AI-driven decision support system. Instead, the devices are cleared based on substantial equivalence to predicate devices.

The "Performance Data" section states:

• "The K&J Consulting - FaSet Fixation System, Huvex Interspinous Fixation System, and AEON-C™ Stand Alone System devices are identical to predicate devices and therefore, no performance testing is required."
• "New components being added to the UNITY Sacroiliac Joint Fixation System, but the new components do not introduce a new mechanical worst-case, so no new testing is required."

Therefore, there is no table presenting acceptance criteria and reported device performance because the regulatory clearance is based on the devices being identical or having similar technological characteristics and not introducing new safety/effectiveness concerns compared to previously cleared devices.

2. Sample Size Used for the Test Set and Data Provenance

Since no new performance testing was required due to substantial equivalence, there is no test set sample size or data provenance mentioned in this document for the subject devices.

3. Number of Experts Used to Establish Ground Truth and Their Qualifications

Given that performance testing was not required for these devices (as they are identical or technologically similar to predicates), there is no mention of experts or ground truth establishment in this context.

4. Adjudication Method

No adjudication method is mentioned as there was no performance testing involving human review of a test set.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No MRMC study was conducted or reported for these devices. The devices are hardware implants, not AI-driven systems where such studies are typically performed.

6. Standalone (Algorithm Only) Performance Study

Not applicable. These are physical implantable devices, not algorithms.

7. Type of Ground Truth Used

No ground truth data was used for the substantial equivalence determination beyond the specifications and established safety/effectiveness profiles of the predicate devices.

8. Sample Size for the Training Set

Not applicable. These are physical implantable devices, not AI/ML algorithms that require a training set.

9. How the Ground Truth for the Training Set Was Established

Not applicable.

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The AEON-C™ Stand Alone System is a stand-alone anterior cervical fusion device indicated for use in skeletally mature patients with degenerative disc disease (DDD) with accompanying radicular symptoms at one or two contiguous levels from C2-T1. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. The AEON-C™ Stand Alone System should be packed with autograft and/or allograft comprised of cancellous, cortical and/or corticocancellous bone graft and implanted with an anterior approach. Patients should receive at least six (6) weeks of non-operative treatment with a cervical intervertebral intervertebral fusion device.

The AEON-C™ Stand Alone System includes PEEK interbodies and titanium interbodies, which utilize a titanium alloy locking mechanism that is either integrated in an anterior fixation plate or within the interbody. Both PEEK interbodies and titanium interbodies, with or without fixation plates, are to be anchored to patient anatomy via two (2) titanium alloy bone screws. The implant design includes multiple footprints, heights and lordosis options and the screw design includes multiple diameters and lengths, to fit a variety of patient anatomies.

The provided text is a 510(k) summary for the Dio Medical AEON-C™ Stand Alone System, which is an intervertebral body fusion device.

1. Table of Acceptance Criteria and Reported Device Performance

This type of medical device (intervertebral body fusion device) does not typically have "acceptance criteria" in the same way software or diagnostic AI devices do, which might involve performance metrics like sensitivity, specificity, or AUC. Instead, for devices like this, acceptance is based on demonstrating substantial equivalence to a legally marketed predicate device, primarily through mechanical testing, biocompatibility, and material characterization.

However, the provided document explicitly states the following under "Performance Data":

2. Sample Size Used for the Test Set and Data Provenance

The document explicitly states: "The subject and predicate devices are identical and therefore, no performance testing is required. Submission is only transferring name of a system that has already been cleared under K191477. No testing is required."

Therefore, there was no new test set used for this particular 510(k) submission (K223140). The device is asserted to be identical to a previously cleared predicate device (K191477).

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

Not applicable, as no new test set or performance study was conducted for this submission.

4. Adjudication Method for the Test Set

Not applicable, as no new test set or performance study was conducted for this submission.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This device is an intervertebral body fusion device, not an AI or imaging diagnostic device that would involve human readers or AI assistance in interpretation.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This device is a physical implant, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

Not applicable, as no new performance study was conducted. For mechanical devices, "ground truth" typically refers to established engineering standards, biomechanical testing results, and clinical outcomes data from prior studies on equivalent devices, which would have been part of the original predicate device's clearance.

8. The sample size for the training set

Not applicable. The device is a physical implant, not an AI model, so there is no "training set."

9. How the ground truth for the training set was established

Not applicable, as there is no training set for this type of device.

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The AEON-C™ Stand Alone System is a stand-alone anterior cervical intervertebral fusion device indicated for use in skeletally mature patients with degenerative disc disease (DDD) with accompanying radicular symptoms at one or two contiguous levels from C2-T1. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. The AEON-C™ Stand Alone System should be packed with autograft and/or allograft comprised of cancellous, cortical and/or corticocancellous bone graft and implanted with an anterior approach.

Patients should receive at least six (6) weeks of non-operative treatment prior to treatment with a cervical intervertebral fusion device.

The AEON-C™ Stand Alone System includes PEEK interbodies and titanium interbodies, which utilize a titanium alloy locking mechanism that is either integrated in an anterior fixation plate or within the interbody. Both PEEK interbodies and titanium interbodies, with or without fixation plates, are to be anchored to patient anatomy via two (2) titanium alloy bone screws. The implant design includes multiple footprints, heights and lordosis options and the screw design includes multiple diameters and lengths, to fit a variety of patient anatomies.

The provided text describes the 510(k) summary for the HUVEXEL Co., Ltd's AEON-C™ Stand Alone System. This is a medical device for orthopedic surgery, specifically for intervertebral fusion, and the information presented is related to its mechanical performance and substantial equivalence to existing devices, not an AI/ML algorithm.

Therefore, many of the requested categories (such as sample size for test set, data provenance, number of experts for ground truth, adjudication method, MRMC study, standalone performance, type of ground truth used, sample size for training set, and ground truth for training set) are not applicable to this type of device and study.

However, I can provide the acceptance criteria and reported device performance from a mechanical testing perspective, based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

Description of the Study that Proves the Device Meets Acceptance Criteria:

The study conducted to demonstrate the AEON-C™ Stand Alone System meets acceptance criteria was a non-clinical performance testing study. This study aimed to show that the subject device is substantially equivalent to legally marketed predicate devices.

Specifics of the Study:

• Type of Study: Non-clinical (mechanical) testing.
• Standards Followed: The testing was performed in accordance with ASTM F2077 (Standard Test Methods for Determining Durability of Intervertebral Body Fusion Device Materials and Constructs in a Corpectomy Model) and ASTM F2267 (Standard Test Method for Measuring Load Induced Subsidence of Intervertebral Body Fusion Device Under Static Axial Compression).
• Tests Performed:
  • Static & Dynamic compression
  • Static & Dynamic compression shear
  • Static & Dynamic Torsion
  • Subsidence
  • Expulsion
• Objective: To demonstrate that the AEON-C™ Stand Alone System is as safe, as effective, and performs as well as, or better than, the legally marketed predicate devices.
• Conclusion: The non-clinical tests demonstrated that the device is substantially equivalent to the predicate devices.

2. Sample Size used for the test set and the data provenance:

• Test Set Sample Size: Not applicable. This was mechanical testing of the device, not a study involving patient data or a "test set" in the context of AI/ML. The sample size would refer to the number of physical devices tested, but this detail is not provided in a 510(k) summary for mechanical testing as it is assumed to be adequate for the standards.
• Data Provenance: Not applicable, as this refers to mechanical testing results, not clinical data or data from a specific country of origin.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience):

• Not applicable. Ground truth as defined in this request (expert consensus, pathology) is relevant for clinical or diagnostic AI/ML studies. This study is mechanical performance testing against established engineering standards. The "ground truth" here is the performance metrics defined by the ASTM standards.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

• Not applicable. Adjudication methods are used in studies where human judgment is involved in establishing ground truth for a clinical or diagnostic outcome. This was mechanical testing.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

• Not applicable. This applied to AI/ML devices, not a physical intervertebral fusion device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

• Not applicable. This applies to AI/ML algorithms. The device itself is described as a "Stand Alone System" in the sense that it is a physical implant, but not in the context of an AI algorithm operating independently.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

• Mechanical Performance Standards: The "ground truth" for this device's performance is compliance with established engineering and biocompatibility standards (e.g., ASTM F2077, ASTM F2267) and substantial equivalence to predicates as demonstrated through comparative mechanical testing and material characterization.

8. The sample size for the training set:

• Not applicable. This applies to AI/ML algorithms, not mechanical device testing.

9. How the ground truth for the training set was established:

• Not applicable. This applies to AI/ML algorithms, not mechanical device testing.

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